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Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation

NCT05988450 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-08-14

No results posted yet for this study

Summary

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment.

Conditions

  • Functional Mitral Regurgitation

Interventions

DEVICE

SQ-Kyrin Transcatheter Mitral Valve Repair System

Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.

Sponsors & Collaborators

  • Shanghai Shenqi Medical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yaling Han, MD, Ph.D · General Hospital of Northern Theater Command, PLA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2023-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05988450 on ClinicalTrials.gov